Solero Microwave Tissue Ablation (MTA) System and Accessories
FDA 510(k) K223581 · AngioDynamics, Inc.
510(k) numberK223581
Submission
- Device name
- Solero Microwave Tissue Ablation (MTA) System and Accessories
- Applicant
- AngioDynamics, Inc.
Marlborough, MA, US - Received
- December 1, 2022
- Decision date
- March 27, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NEY – System, Ablation, Microwave And Accessories
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4400
- Specialty
- General, Plastic Surgery
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| K240480 | IntelliBlate Microwave Ablation System Console (IB-CON); IntelliBlate Microwave Ablation…NEY · Traditional | Varian Medical Systems, Inc. | 07/19/2024SE |
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| K240518 | swiftPro SystemNEY · Traditional | Emblation Limited | 04/23/2024SE |
| K233838 | Emprint Ablation System with Thermosphere Technology (Overall System Name); Emprint…NEY · Special | Medtronic, Inc. | 03/28/2024SE |
| K233140 | Microwave Ablation Device (Exceed S10U); Sterile Microwave Ablation Probe (Exact)NEY · Traditional | Hygea Medical Technology Co., Ltd. | 01/31/2024SE |
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| K231945 | VenaCure EVLT NeverTouch Procedure Kits; VenaCure EVLT NeverTouch Direct Procedure KitsGEX · Special | 07/20/2023SE |
| K221883 | Solero Microwave Tissue Ablation (MTA) System and AccessoriesNEY · Special | 03/07/2023SE |
| K213388 | AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 SystemQEZ · Traditional | 04/04/2022SE |
| K213067 | Solero Microwave Tissue Ablation (MTA) System and AccessoriesNEY · Special | 12/03/2021SE |
| K212386 | AngioVac F18 85DWF · Traditional | 09/30/2021SE |
Questions and answers
When was Solero Microwave Tissue Ablation (MTA) System and Accessories cleared by the FDA?
Solero Microwave Tissue Ablation (MTA) System and Accessories (K223581) received a 510(k) decision of Substantially Equivalent on March 27, 2023, 116 days after the submission was received.
What is the product code of K223581?
The FDA product code is NEY – System, Ablation, Microwave And Accessories, a Class II (moderate risk) device regulated under 21 CFR 878.4400.